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Commenting on Comments:  The Ceftaroline Trial Program in CABP

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The ceftaroline (Teflaro®) program was executed at a time when FDA was debating a new CABP Guidance with new outcome measures: no longer was the time-honored TOC assessment acceptable, instead improvement on Day 3-5 was to become the new primary endpoint.  FDA made other significant changes to the old 1998 Continue reading Commenting on Comments:  The Ceftaroline Trial Program in CABP→

Why Some Did Not Make It

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There are numerous reasons why drugs get stuck in development.  Certainly, problems with efficacy or problems with safety are main reasons but there are many other ‘derailers’ as well.  For instance regulatory issues or manufacturing, difficulties can stop a program.  Occasionally, a suboptimal dose was chosen because of (1) incomplete Continue reading Why Some Did Not Make It→

It’s Not a Free-Enterprise Market, Stupid!

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The economics of developing antibacterials is a frustrating topic to address.  There are unique aspects to the antibiotic market which sets it apart from other medicines, esp. the unique societal aspects of antibiotic use which go beyond the benefit to the individual. IDSA has spoken out in various publications (“Bad Continue reading It’s Not a Free-Enterprise Market, Stupid!→